Insulet

What is established and what is not

No facet of this company has been investigated yet. The facts below are collected records, not an assessment: nothing here confirms manufacturing, ownership or trading status beyond what each record literally says.

Verified facts

• corporate-mail-on-domain (green), checked 2026-08-08 Mail server of the company domain
• domain-registered (green), checked 2026-08-08 Domain registry record
• sanctions-clear (green), checked 2026-08-08 OpenSanctions
• debarment-clear (green), checked 2026-08-08 OpenSanctions
• lei-lapsed (amber), checked 2026-09-07 GLEIF global LEI register (golden copy)
• registry-id-verified (green), checked 2026-09-10 GLEIF Global LEI record

Claimed certifications, not confirmed by us

• ISO 13485, Medical Devices Quality IAF CertSearch
• FDA Registered FDA Establishment Registration

Import rules for these goods

• Medical devices sold in the EU must carry CE marking under the Medical Device Regulation (EU) 2017/745, with a conformity assessment matched to the device risk class. European Commission (MDR)
• For the US market, the maker must have an FDA device establishment registration and product listing; most instruments also need 510(k) premarket clearance. US FDA (devices)
• Electronics for the EU need CE marking incl. RoHS substance limits, and producers must register for WEEE take-back in each member state of sale. European Commission (CE)
• Electronics for the US market need FCC equipment authorization under 47 CFR Part 15, which covers unintentional radiators such as switch-mode power supplies, not only radio devices. US FCC (Part 15)

Check independently

• Sanctions and watchlists (OpenSanctions)